雅培血糖仪存在未公开缺陷,导致七名糖尿病患者死亡。
Seven Diabetes Patients Die Due to Undisclosed Bug in Abbott's Glucose Monitors

原始链接: https://sfconservancy.org/blog/2025/dec/23/seven-abbott-freestyle-libre-cgm-patients-dead/

布拉德利·库恩讲述了他作为新诊断糖尿病患者使用连续血糖监测仪(CGM)——特别是雅培公司的FreeStyle Libre Plus的经历。他强调了专有医疗设备令人担忧的现实,以及医疗系统,尤其是在美国,缺乏透明度的问题。 库恩收到了一份可怕的警报,雅培公司召回了与七名患者死亡和超过700人受伤相关的设备,原因是导致血糖读数虚假的错误。他发现自己最近使用过受影响的设备,由于他处于糖尿病早期,侥幸避免了严重伤害。 这一事件凸显了一个更广泛的担忧:闭源医疗软件可能造成的危害。库恩倡导自由和开源软件(FOSS)的好处,以及公开硬件规格,以便进行更广泛的同行评审和提高安全性。虽然他承认FOSS并非万无一失,但他认为它促进了一种更具协作性和问责性的方法。 他对法律障碍表示担忧——特别是雅培公司服务条款中的免责条款——并呼吁进行独立调查和潜在的集体诉讼。库恩正在积极寻找志愿者来逆向工程该设备硬件,并为像Juggluco这样的FOSS替代方案做出贡献。

七名糖尿病患者因雅培血糖仪未公开的漏洞去世 (sfconservancy.org) 25点 由 pabs3 2小时前 | 隐藏 | 过去 | 收藏 | 1条评论 gustavus 0分钟前 [–] 我妻子使用CGM,并且依赖一个据称可以“自动”与她的传感器协调,在她检测到血糖过高/过低时输送或减少胰岛素的精巧胰岛泵。作为一名安全专家,我一直对编写控制这些设备的那些人持怀疑态度。 但我很想参与、贡献或以某种方式帮助逆向工程、开源,或者确保我妻子的生命不依赖于他们可以外包给最低报价者的软件质量。如果有人知道我如何提供帮助,请告诉我该联系谁。 指南 | 常见问题 | 列表 | API | 安全 | 法律 | 申请YC | 联系 搜索:
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原文

by Bradley M. Kühn on December 23, 2025

I wrote last month about my diabetes diagnosis this year and my difficult choice to wear a proprietary device (called a CGM) on my arm 24/7 to continuously monitor my glucose levels. Like my friend and colleague, Karen M. Sandler — who previously made a much higher-stakes choice to receive a proprietary implanted defibrillator to keep her safe given her genetic heart condition — I reluctantly chose to attach proprietary hardware and software to my body.

The device itself is quite proprietary, but fortunately the FOSS community has reverse engineered its activation and data collection protocols — creating an Android application that does a better job than the manufacturers' proprietary ones0.

Here in the USA, we strangely use capitalism as the center of our health care system. Two major for-profit competing brands of CGM are available here. My diabetes specialist prefers the (ironically named) Freestyle Libre Plus from Abbott. I (also rather strangely) bring a prescription for electronics to a pharmacy every month. On 2025-12-03, that phramacy sent me an alarming text message (shown here).

Abbott Killed Seven Patients

After reading that text, I found the USA FDA announcement. My spouse cross-referenced the lot numbers while I read them off from all my Freestyle boxes1. I had indeed recently worn an impacted device!

Only because my diabetes is so early of a stage was I relatively safe. The FDA reports that Freestyle injured over 700 people and killed seven people with this bug. Spcifically, the bug caused the device to falsely report an extremely low glucose level. Advanced stage diabetics use low reading information to inform them that they may have too much insulin currently. The usual remedy is to eat something sugary to raise glucose in the blood. Such should be done only with great care, as a false low reading can harm and even kill the patient (who eats a high-sugar-content item while glucose in the blood is, in fact, not low).

Proprietary software in medical devices harming patients is not new. In 1985, the Therac-25 killed three people. In 2020, hundreds of patients who relied on a financially troubled tech startup found their occular implants suddenly unsupported. Some patients went blind as the devices powered down without updates. There are more examples that I could include here, but rereading this horrific stories is frankly more than I can take right now when I think of fellow diabetes sufferers who were “killed by code” recently..

Would FOSS Have Saved Patients' Lives?

It's hubris for activists to guarantee that harm would be prevented if Freestyle had publicly released the hardware specifications and the complete, corresponding source code (CCS). FOSS isn't immune to bugs — even dangerous ones. However, in the centuries since the Enlightenment, we know that the scientific method depends on public disclosure about data and wide-reaching peer review of past work. FOSS (plus a publicly disclosed hardware design) wouid allow the millions of hardware and software engineers to peer-review the integrity, security, and safety of the devices to which patients entrust their lives. We achieve the promise of humanity when we each entrust our safety and health to our entire community — not merely a single for-profit entity.

We also will probably never know whether this issue was in hardware or software. The bug disclosure is incredibly vague, and it remains unclear how much investigation was done (if any) by government regulators into this problem. As a public policy and public health matter, the public deserves to know the technical details (software and hardware) of both the functioning device and the failed devices. NGOs should be permitted to perform their own investigations and confirmations of public safety.

What's Next?

Given that the hardware, software, and medical for-profit industries refuse to put the rights, safety and security of patients first, wrongful death lawsuits are typically the only way to hold these companies accountable. Yet, there are very few people who have not agreed Abbott's toxic terms of their proprietary companion application — I guestimate that fewer than 1% of Freestyle-using patients have used Juggluco from their very start (and thus never agreed to Abbott's terms). This is significant because Abbott includes a comprehensive one-way indemnity for themselves in the terms. I hope that a class action suit begins soon on this matter, but I wonder and worry that so much of the class may have signed this indemnity (which may make the road to justice bumpier).

Finally, I want to offer that if there is anyone out there who does tear-downs of extremely tiny electronic devices, I would be thrilled to find a volunteer who would like to see if we can either extract any software components from the device, or reverse-engineer the hardware. I have saved and sanitized all of my prior CGMs. I'd gladly send one along to anyone who wants to give a try at taking them apart. (Contact SFC or contact me on the Fediverse (via Mastodon) if you're available to do this work.)

For my part, I look forward (after the Vizio trial) to sending some patches to Juggluco and also getting Juggluco available in F-Droid. Our best option in the face of these powerful medical device companies curtailing our rights is to invest our volunteer time into the edges where FOSS has resiliently worked around the constant roadblocks erected by bad actors.

My prior post about CGMs discussed the GPLv3'd Juggluco in more detail.

In a fascinating turn of events, at least one of my past monitors (of which I fortitously saved all the boxes with the lot/serial number on them) is listed in the FDA's spreadsheet as recalled lot, yet the serial number is listed as “ safe to use” on Abbott's webform 🤔 … I'm left wondering how I can trust Abbott to write reliable software stuck into my arm if they can't even write a web form that cross-references serial numbers to lots correctly 😬.

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